Biosafety Procedure
1.
2.
3.
4.
5.
Purpose and Scope .......................................................................................................................................................... 1
Definitions ........................................................................................................................................................................ 2
Biosafety Procedure ........................................................................................................................................................ 4
3.1
Regulatory processes ........................................................................................................................................ 4
3.1.1
Australian Standards ................................................................................................................................... 4
3.1.2
OGTR ........................................................................................................................................................... 4
3.1.3
DAFF ............................................................................................................................................................ 4
3.1.4
SSBA .............................................................................................................................................................. 4
3.1.5
DoHA............................................................................................................................................................ 4
3.2
Biosafety Risk Management Process ............................................................................................................ 4
3.2.1
Identification of Biological Hazards and Specific Legislation ............................................................. 5
3.2.2
Assessing the Risk from a Biological Hazard. ........................................................................................ 5
3.2.3
Identifying the controls, including containment facility level.............................................................. 5
3.2.4
Obtaining approval for use of the biological material .......................................................................... 7
3.2.5
Table 1: Approval Matrix and Legislation .............................................................................................. 7
3.2.6
Table 2: List of SSBAs................................................................................................................................ 8
3.3
Registration and Decommissioning of Containment Facilities ................................................................ 8
3.3.1
Registration................................................................................................................................................... 8
3.3.2
Decommissioning of physical containment facilities............................................................................ 8
3.3.3
Cessation of an individual’s work ............................................................................................................. 9
3.4
HS incident reporting requirements.............................................................................................................. 9
3.5
Responsibilities ................................................................................................................................................. 9
3.5.1
The Head of School is responsible for: ................................................................................................... 9
3.5.2
The Principal Investigator (PI) or Facility Manager (FM) is responsible for: ................................. 10
3.5.3
SSBA facilities ............................................................................................................................................ 10
Review ............................................................................................................................................................................. 10
Acknowledgements & History .................................................................................................................................... 10
5.1
External references......................................................................................................................................... 10
5.2
UWA references & associated documents ................................................................................................ 11
5.3
Appendix A: History...................................................................................................................................... 11
5.4
Appendix B: Summary of changes .............................................................................................................. 12
1. Purpose and Scope
UWA, as an educational and research institution, seeks to provide a structured approach to preventing
staff and student exposure to biological hazards.
This Procedure was written to help staff and students identify and meet various related legislative and
regulatory requirements. The University will follow the relevant legislation and standards, such as
those prescribed by OGTR, DAFF and Australian Standards (see Section 5).
This Procedure is for staff, students and visitors who carry out work, research or study at UWA, in a
clinical environment, laboratory, research facility, plant, insect or animal facility, and who may handle
or are potentially exposed to biological hazards. These hazards include, but are not limited to:
 microorganisms;
 animals (including their tissues, dander, blood or body fluids and excreta);
 plants, insects (or parts of);
 human blood, tissues and body fluids and excreta;
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

materials that have been contaminated or are potentially contaminated with infectious
microorganisms.
imported biological materials (any of the items listed above)
2. Definitions
DAFF – Department of Agriculture, Forestry and Fisheries, formerly AQIS (Australian Quarantine
Inspection Service)
Biosafety – a combination of systems and practices intended to reduce the risk of accidental
exposure to, or release of, agents that cause infectious disease.
Biological Hazard, Biohazard, Biologically Hazardous Material - any biological agent, substance
or material (whether alive or not) present in or arising from living organisms, that are or may be
hazardous to the health or well being of the (UWA) community or environment.
Biosafety Supervisor – the local person assigned by the school or research group who is the contact
person for the exchange of information with the Biosafety Office related to all matters of biosafety.
Biosafety Coordinator – the UWA Biosafety Manager
Diagnosis - The process of determining the nature of a disease or disorder and distinguishing it from
other possible conditions.
Diagnostic Specimen
 any human or animal material, including (but not limited to) excreta, secreta, blood and its
components, sputum, tissue and tissue fluids, submitted for the purposes of diagnosis.
 Diagnostic specimens from humans or animals would normally be regarded as
Risk Group 2 and shall be handled in Physical Containment Level 2 facilities (see
definitions below). This applies in all microbiology and other pathology
laboratories, e.g. pathology or mortuary.
 If a microbial pathogen of a higher risk group is isolated from a specimen, it shall be
handled according to the corresponding risk group, and at the appropriate
physical containment level.
Note - All diagnostic samples shall be treated with care as they may contain multiple types of pathogens.
DoHA – Australian Government’s Department of Health and Aging
Gene Technology – any technique for the modification of genes or other genetic material, but does not
include:
a. sexual reproduction;
b. homologous recombination;
c. any other technique specified in the regulations for the purposes of this paragraph.
Genetically Modified Organism (GMO) – means:
a. an organism that has been modified by gene technology;
b. an organism that has inherited particular traits from an organism (the initial organism),
being traits that occurred in the initial organism because of gene technology;
c. anything declared by the regulations to be a genetically modified organism, or that belongs to
a class of things declared by the regulations to be genetically modified
organisms; but
does not include:
d. a human being, if the human being is covered by paragraph (a) only because the
human being has undergone somatic cell gene therapy; or
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e. an organism declared by the regulations not to be a genetically modified organism, or that
belongs to a class of organisms declared by the regulations not to be genetically modified
organisms.
OGTR – Office of the Gene Technology Regulator
Physical Containment (PC) Facility
 the laboratory, room, facility or building that has been constructed and furbished to specific
Australian Standard (AS/NZS 2243.3) requirements, in order to physically contain
microorganisms, animals, plants, insects or biological hazards, and in order to protect people
and the environment.
 a defined place where research and teaching involving biohazards is undertaken.
 includes laboratories, animal houses, plant houses, insectaries etc.
PC 1, PC2, PC3 and PC4 – Physical Containment Facility Level 1 to Level 4
 As described in AS/NZS 2243.3, for handling material of the corresponding Risk Group
level.
 As described by the OGTR to explain the categories of organisms and types of
dealings intended to be contained in each facility type. These levels are
intended to harmonise as closely as possible with the PC levels described in AS/NZS 2243.3.
PPE – Personal Protective Equipment (includes clothing)
Principal Investigator or Facility Manager – that person who is responsible for the allocation of
tasks to staff, students and visitors; and/or the oversight of a containment facility or research project.
Risk Group
 the classification of microorganisms based on the pathogenicity of the agent, the mode of
transmission, host range, availability, effectiveness of preventative measures and availability
of treatment
 Risk Group 1 through to Risk Group 4 (lowest risk through to highest risk) as
described in AS/NZS 2243.3, to be handling in the corresponding Physical
Containment level. The risk group classifications describe infectious microorganisms for humans and animals, plants and also invertebrates.
SSBA – Security Sensitive Biological Organisms according to the Department of Health and Aging
(See Table 2)
Standard Precautions –
 the basic risk minimisation strategy for the handling of human blood and body fluids,
secretions and excretions (excluding sweat), and for contacting non-intact skin and mucous
membranes. The strategy is recommended by DoHA (see the DoHA, Infection control
guidelines)
 the work practices required for the basic level of infection control. They include the use of:
o good microbiological practices (e.g. aseptic techniques);
o good hygiene practices (particularly washing and drying hands before and
after patient and specimen contact);
o protective barriers (including the wearing of gloves, gowns, plastic aprons, masks,
eye shields and goggles);
o waterproof coverings over any break in skin integrity;
o appropriate procedures for the handling and disposal of contaminated
wastes; and
o appropriate procedures for the handling and disposing of sharps.
 The work practices described in Clause 5.3.6 of AS/NZS 2243.3 (PC2 Work
Practices) meet the requirements of implementing Standard Precautions.
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3. Biosafety Procedure
3.1 Regulatory processes
All research or teaching involving microbiological organisms, diagnostic samples, human and animal
tissues, blood or bodily fluids, insects and general biological hazards must follow the requirements of
the UWA Biosafety Procedure.
All biological hazards used at UWA can be segregated into one or more of the following Standards or
Regulatory processes:
3.1.1 Australian Standards
AS/NZS 2243.3 Safety in the Laboratories (Series): Part 3: Microbiological safety and
containment, where ever animal, insect, microorganism (including prions), diagnosis, research,
teaching, quality control and regulatory analysis, is undertaken.
3.1.2 OGTR
When working with GMOs, researchers must also follow the UWA Gene Technology
Procedure which is based on the legislative requirements for gene technology. This includes
researchers having applications for their work assessed by the UWA IBC, and ensuring that their
facility is appropriate, and where applicable, that their facility is certified with the OGTR before
research begins.
Where a researcher has a grant application approved through UWA, but has their GMO work
approved by an IBC other than UWA, the UWA IBC must be notified of the nature of the
project.
3.1.3 DAFF
When working with imported materials for research and/or teaching, Staff, students and visitors
must follow the specific requirements established by DAFF. The biohazard and the facility may
need to be registered with DAFF.
3.1.4 SSBA
A small number of biological agents have been identified as posing a possible threat to National
Security and must only be handled in a registered facility that has approved security measures and
procedures in place.
3.1.5 DoHA
All research or teaching within a non-laboratory, clinical environment with patients must follow
the requirements of DoHA. These requirements are found in the Standard Precautions, defined
above.
Note – If you intend to use biological hazards you must meet the requirements outlined in this document.
There may be other associated requirements, such as complying with Radiation safety, Human and
Animal Ethics, and transportation. See the Register of Biosafety Legislation in section 5.2.
3.2 Biosafety Risk Management Process
UWA has provided this Biosafety Procedure to assist researchers and students in continuously
improving their ability to use biological hazards in a safe, effective manner. The procedure is an
element of the UWA risk management process.
To control biological hazards at UWA you must use the UWA Biological Risk Assessment and
Control Procedure which needs to cover the activities identified in the Biosafety risk management
process listed below.
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There are 4 main steps in the biosafety risk management process:
1. Identify the biological hazard and governing regulatory requirements.
2. Assess the risk from the biological hazard using the risk grouping system from AS/NZS
2243.3.
3. Identify the containment facility level and containment controls based on the risk
group of the organism or material.
 Facility type and containment level PC 1 to PC4
 Containment equipment
 Work practices and other controls
 PPE
4. Identify and obtain:
a. approval for use of the facility and the
biological material.
b. training needs
3.2.1 Identification of Biological Hazards and Specific Legislation
When a biological hazard has been identified it must be recorded on your Laboratory/Facility
Microorganism/Biohazard Register and Safety and Health Risk Register (see
www.safety.uwa.edu.au/management/risk-register).
After identification of your biological hazard(s) you must determine what legislation is relevant
to the biological hazard you will be using. The specific legislation will determine any additional,
specific controls that may need to be implemented. See Table 1: Approval Matrix and
Legislation, and the Register of Biosafety Legislation for information about relevant legislation.
Record the specific legislation on your Safety and Health Risk Register.
3.2.2 Assessing the Risk from a Biological Hazard.
All biological hazards need to be assigned a risk group (1 – 4) using AS/NZS 2243.3 as the
primary assessment tool. A risk assessment is to be conducted, covering 2.1.2(a-j) of AS/NZS
2243.3. If it is unclear to which risk group an organisms or biological hazard belongs, contact
your local biosafety supervisor to assist you.
It is important to also check whether the biological agent is listed in Table 2, paragraph 3.2.6. If
your agent is listed in this table, you must contact the Biosafety Coordinator before bringing the
agent into the University, unless DoHA has already approved your research and written
procedures, and has registered your facility.
3.2.3 Identifying the controls, including containment facility level
When working with biological hazards in a laboratory, animal house or any other facility, it is
necessary to define the level of physical containment (PC 1 – 4). This is based on the risk group of
the biohazard.
Control – containment facility level
There are 4 different physical containment levels ranging from PC1 to PC4. Each containment
level corresponds directly to the 4 risk groups of biological hazards as set out in AS/NZS
2243.3. The higher the risk group rating, the higher the facility containment level required, and
the higher the risk to laboratory workers and community.
The level of physical containment that is identified will dictate the facility’s structural
requirements, containment equipment, work practices and PPE requirements that are necessary
to work safely with the designated risk group.
If it is unclear which level of physical containment is required, contact your local biosafety
supervisor to assist you.
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Controls - containment equipment
All UWA physical containment facilities are required to implement the controls identified in
AS/NZS 2243, Sections 4 to 8. These are the minimum safety standards for working with
biological hazards.
Your risk assessment may identify additional controls that might be needed to be
implemented, as may any specific legislation that has been identified.
Controls - health management
 Personnel shall have an initial medical examination (including any specific tests such as a
chest x-ray, if relevant) and periodic monitoring examinations when working with
pathogens of Risk Group 3 or 4. A baseline blood serum sample should be obtained
and stored for future reference.
 Laboratory management shall inform female employees of risks of exposure to
themselves if pregnant, or of risks to the unborn child from certain
microorganisms eg Toxoplasma gondii, Listeria monocytogenes,
cytomegalovirus, parvovirus B19, rubella virus, human immunodeficiency virus
(HIV), Coxiella burnetii, hepatitis B, C and E viruses, and some fungi.
 The Facility Manager or Head of the research group must, on learning of a suspected or
actual laboratory acquired illness related to a research-related
biological agent, immediately report the matter to the Biosafety Manager.
Controls - immunisation
Staff or students at UWA may be at an increased risk from preventable diseases if they are:
 Working with infectious organisms;
 Working with human blood or body fluids;
 Working with non-human primates;
 Working with animals and/or insects;
 Working with infected plants or soil;
 Working with waste water;
 Working in child care facilities;
 A person administering first aid;
 A cleaner or maintenance worker;
 A member of Security Staff;
 Conducting fieldwork;
 Travelling overseas
 Participating in some field trips
 A person who is immunosuppressed or immunocompromised.
 Possibly exposed to tetanus include staff and students who:
 work with all types of animals
 are gardeners
 are Facilities & Services staff (not office based)
 may be exposed to raw sewage during work activities i.e. plumbers, staff
involved in water studies
Immunisation requirements:
 Where a risk assessment has identified that a person is carrying out University-related
work and where there is the potential risk from infectious
diseases that are vaccine-preventable, the following must be offered:
 relevant information relating to their possible exposure and relevant
vaccination information;
 prompt and appropriate immunisation.
Immunisation guidelines:
 The following information and guidelines are available to assist in the
identification of appropriate immunisation:
 The Australian Immunisation Handbook (NHMRC, 2008)
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 UWA Immunisation Guidelines
(http://www.safety.uwa.edu.au/topics/biological/immunisation)
Controls - work practices
AS/NZS 2243.3 identifies the work practices that are applicable for working at each of the
physical containment levels for each type of containment facility – laboratory, animal, plant and
invertebrate (sections Sections 5 – 8 respectively).
Note:
 Containment Facility Signage
Once the physical containment level is determined, the laboratory/room must have
correct signage placed on all entrances (the Biosafety Office will provide you with PC2
signage).
 Documentation
Laboratories are required to have in place documentation of all management system
components, as described in AS/NSZ2243.1, (Sections 3 and 4). All
appropriate procedures must be documented and implemented.
Documentation includes:
 Risk assessments, including for working in isolation
 Safe work procedures
 Register of biological materials
 Identification of PPE
 Training
 Health surveillance
 Emergency procedures such as spill response, emergency shutdown of
equipment, evacuation
 Accident and incident reports, investigations and corrective actions
 A draft Laboratory Manual guideline and template, available on request from the
Biosafety Coordinator, may assist laboratory managers and supervisors
in developing their laboratory management system, if one is not already in place.
3.2.4 Obtaining approval for use of the biological material
All research and teaching involving biological hazards must have documented approval
from a UWA approved authority (see Table 1).
You must also check whether your biological hazard is included in the list of agents that are
considered a National Security risk (see Table 2). If your biological hazard is included in Table
2, you must contact the Biosafety Coordinator before any decision is made to bring the agent
onto UWA property.
3.2.5 Table 1: Approval Matrix and Legislation
Biological Hazard
Microorganism Risk
Group 1 -2
Microorganism Risk
Group 3 -4
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UWA
Approval Mechanisms
Governing Standard or
Regulation
HOS/Supervisor
AS 2243.3
HOS
UWA Biosafety Manager
UWA IBC
DVC(R)
AS 2243.3
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Genetically Modified
Organisms
HOS/Supervisor
UWA IBC DVC(R)
OGTR
AS 2243.3
Gene Technology
Legislation
Security Sensitive Biological
Agents
HOS
UWA IBC
DVC(R)
DoHA
HOS/Supervisor
Animal Ethics Committee
(AEC)
DVC(R)
HOS/Supervisor
Human Research Ethics
Committee (HREC)
DVC(R)
HOS
DAF
F
National Security legislation
Animal tissue, blood or body
fluids use
Human tissue, blood or
body fluids use
Import or Export of
Biological Materials
Animal Research Act
NHMRC
AS 2243.3
NHMRC
Human Research Ethics
Handbook
AS 2243.3
Quarantine Act
AS 2243.3
3.2.6 Table 2: List of SSBAs
Tier 1 Agents
Tier 2 Agents
Abrin (reportable quantity 5 mg)
Bacillus anthracis (Anthrax—virulent
strains)
Botulinum toxin (reportable quantity 0.5 mg)
African swine fever virus
Capripoxvirus
(Sheep pox virus and Goat pox virus)
Classical swine fever virus
Ebolavirus
Clostridium botulinum
(Botulism; toxin-producing strains)
Francisella tularensis (Tularaemia)
Lumpy skin disease virus
Foot-and-mouth disease virus
Highly pathogenic influenza virus, infecting
humans
Marburgvirus
Ricin (reportable quantity 5 mg)
Rinderpest virus
SARS coronavirus
Variola virus (Smallpox)
Yersinia pestis (Plague)
Peste-des-petits-ruminants virus
Salmonella Typhi (Typhoid)
Vibrio cholerae (Cholera)
(serotypes O1 and O139 only)
Yellow fever virus (non-vaccine strains)
3.3 Registration and Decommissioning of Containment Facilities
3.3.1 Registration
All PC2 – PC4 laboratories must be approved by and registered with the UWA Biosafety
Office.
3.3.2 Decommissioning of physical containment facilities
Any facility that will cease to function as a containment facility must be appropriately
decommissioned and the Laboratory Decommissioning Checklist completed. A copy of the
completed form must be sent to the School/Unit Biological Safety Supervisor and UWA
Biosafety Manager.
Where the facility is certified with the OGTR, the laboratory manager must contact the
Biosafety Manager in order to have the certificate surrendered. A decommissioned laboratory
must have all certificates and hazard stickers removed from the door(s).
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Areas, equipment and surfaces that need to be disinfected must be identified (including
benchtops, floors, surfaces of equipment, glassware and other potentially contaminated places
such as hoods, water baths, centrifuges, refrigerators, incubators, walls, sinks etc). The
appropriate disinfectant needs to be identified (see AS/NZS2243.3:2010 Appendix F) and used
according to this Standard and the manufacturer’s recommendations.
A final Laboratory Decommissioning Checklist is to be completed and posted on the door of the
laboratory certifying that the area is now able to be safely accessed by other personnel and a copy
of the certificate is to be retained with the laboratory records. This can be accessed at
(http://www.safety.uwa.edu.au/topics/laboratory)
3.3.3 Cessation of an individual’s work
The Cessation of Laboratory Activities checklist is intended to assist researchers in ensuring that
their laboratory space is left in a satisfactory, safe condition once their research has been
completed and before they leave. All biological, chemical and plant hazards must either be
disposed of, or the responsibility for the control of the hazard and all relevant documentation is
assigned to another person.
The completed checklist is then given to the Principal Researcher or Head of School or Centre
(as applicable).
3.4 Safety and Health incident reporting requirements
1. Any illness or injury sustained in association with UWA research activities must be reported
using the UWA Confidential Incident/Injury/Near Miss Report Form
(http://www.safety.uwa.edu.au/incidents-injuries-emergency/notification).
2. Any injury, or any suspected or actual laboratory acquired illness (related to carrying out work
with a research-related biological agent) must be reported to the Biosafety Manager and also
to the Facility Manager or Head of the research
group.
3. WorkCover reportable incidents: With respect to biological research, the Head of School/
Research group or the facility manager must notify their Faculty
Coordinator or UWA Health, Safety and Wellbeing Office immediately on being notified
about a WorkCover reportable incident, which include:
 Death
 Requiring immediate hospital admission as an in-patient
 Requiring medical treatment within 48 hours of an exposure to a substance
 An infection attributed to work with a microorgansism, human blood or body
substances, animals, animal parts or animal waste products
 Contracting any of the following zoonotic disease while working with
animals, animal parts or animal waste products:
 Q-fever
 Anthrax
 Leptospirosis
 Brucellosis
 Hendra Virus
 Avian flu virus
 Psittacosis
Refer also to:
 WHS Act 2011 Part 3, Section 35, and WHS Regulations 2011 Part 11.3,
Clause 699 for the full description of Incident Notification requirements
 UWA Animal Research Risk Identification guideline for further information
regarding risks associated with animals in research and suggested controls.
3.5 Responsibilities
3.5.1 The Head of School is responsible for:
 ensuring research or teaching using biological hazards is approved (Table 1)
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 ensuring containment facilities are appropriate for all teaching and research activities
involving biohazards;
 appointing a containment facility manager for all containment facilities;
 ensuring that all persons are appropriately trained and that training records are kept;
 appointing a Biosafety Contact Person for the School.
3.5.2 The Principal Investigator (PI) or Facility Manager (FM) is
responsible for:
 establishing and implementing systems to meet the objectives set forth in this procedure.
This responsibility extends to all aspects of biological hazardous research involving all
individuals who enter or work in the PI's/FM’s containment facility or collaborate in
carrying out the PI's/FM’s research or teaching.
 Implementing and maintaining a register of all biological hazards within their control;
 Ensuring plant and equipment is decontaminated and a Laboratory Decommissioning
Checklist is in place before contractors are brought in to service/repair plant
and equipment.
 ensuring that biological wastes generated by their activities, or the containment facility that
they supervise, is stored, decontaminated and disposed of according to standard
Laboratory Hazardous Waste Disposal Procedures.
 registering all PC2 – PC4 containment facilities with the Biosafety Office.
 Maintaining a register of all biological material (microorgansism, biohazard register)
 assessing the risk of exposure of staff and students to vaccine-preventable diseases
and identifying the subsequent need for immunisation;
 providing immunisation to all staff, post graduate and Honours students where required;
 storing immunisation records according to UWA Archives and Records
Procedure.
 obtaining all legislative approvals that are required.
 Ensuring that a facility is fully decommissioned once it ceases to function as a
containment facility.
 Ensuring that departing personnel make their work space safe and reassign
responsibility for the control of any remaining biological, chemical and plant
hazards to others before they leave.
3.5.3 SSBA facilities
 The Responsible Officer (or Deputy Responsible Officer) must notify the UWA Biosafety
Coordinator of any communications to or from DoHA. Communication would include
the annual report to DoHA, notice of an annual inspection by DoHA, inspection
reports, notice of changes to the registration of the facility (for example, changes in
personnel, additions or subtractions to the list of SSBAs, breaches in security,
requirements for corrective actions).
4. Review
This procedure will be reviewed in accordance with the OHS Management Review Procedure.
5. Acknowledgements & History
5.1 External references
WHS Act 2011
WHS Regulations 2011
Australian Standards:
 AS/NZS 2243 Safety in laboratories, 10 part series
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o Part 1: Planning and operational aspects
o Part 3: Microbiological safety and containment
Australian Quarantine
Dept Health and Aging:
 Gene Technology
 SSBA
 Infection control guidelines 2010
National Health and Medical Research Council NHMRC
Infection control guidelines for the prevention of transmission of infectious diseases in the
health care setting, NHMRC, 2010
The Australian Immunisation Handbook, 9th edition, NHMRC, 2008.
5.2 UWA references & associated documents
5.3 Appendix A: History
Versions under current format
Version
Authorised by
Approval Date
Effective Date
1.1
IBC, Safety and
Health
7/11/2013
12/2013
Biosafety Procedure
2014
Sections modified
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Biosafety Procedure
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